ExoAtlet (exoskeleton)

Main article: Exoskeletons

ExoAtlet - rehabilitation medical exoskeleton.

2021

Testing of new exoskeletons in Moscow city rehabilitation centers

In urban rehabilitation centers in Moscow, new exoskeletons began to be tested. This was reported on September 22, 2021 in the capital's social development complex.

Our mission is to find promising technologies, select the best and introduce them into the Moscow health system. The main freelance specialists of the health department praised the developments of Exoatlet, and we launched the testing of exoskeletons on the basis of medical rehabilitation centers, "said Vyacheslav Shulenin, general director of the Moscow Center for Innovative Technologies in Healthcare of the Social Development Complex of the Russian capital (quote from TASS).

Adult devices and exoskeletons for Bambini children will be tested, which are equipped with the function of extra steps - an important exercise for the development of children diagnosed with cerebral palsy. They also have a separate drive on the roll of the foot so that the child can put his foot on his heel, and then smoothly roll it on his sock.

In urban rehabilitation centers in Moscow, 60 patients began to test new exoskeletons

More than 60 patients will take part in the study on the site of the Scientific and Practical Center for Pediatric Psychoneurology. According to its results, the influence of exorehabilitation on the restoration of motor functions in children will be analyzed and methodological recommendations for the use of exoskeleton will be developed.

As the director of the Scientific and Practical Center for Pediatric Psychoneurology and the Chief Freelance Specialist in Pediatric Neurology of the Moscow Department of Health Tatyana Batysheva noted, the appearance of an exoskeleton for children is a real breakthrough. With its help, rehabilitation and habilitation go to a completely new level.

Our small patients are already taking their first steps with Exoatlet Bambini despite severe pathologies. Earlier, the Center for Pediatric Psychoneurology took part in the development of this equipment, and now post-registration studies are taking place on its basis, "she said.[1]

FDA certification and entry into the US market

On August 5, 2021, ExoAtlet was announced to enter the American market. According to the press service of the Skolkovo Foundation (the developer of exoskeletons is its resident), the US Food and Drug Administration (FDA) has issued permission to sell medical exoskeletons ExoAtlet II.

It is noted that certification confirms compliance with the norms and standards of national legislation and opens up the opportunity for ExoAtlet products to enter the American market.

Obtaining a permit was the American office of ExoAtlet, opened in 2018. The procedure of confirmation of clinical safety and efficiency of an exoskeleton of ExoAtlet II included clinical trials. To conduct them, the company passed an ethical committee to comply with the standards of Good Clinical Practice.

Russian exoskeleton developer ExoAtlet enters the American market

The potential volume of the exorehabilitation market in the United States makes it one of the key ones for ExoAtlet. The number of annual strokes in the country is more than 795,000 and about 4 times higher than in Russia. Almost 18,000 Americans a year receive traumatic spinal cord injuries, the number of annual endoprosthesis surgeries will reach 4 million by 2030.

Earlier, Model ExoAtlet II has already passed medical certification in Europe (CE Mark), South Korea (KFDA) and Russia (RU), which confirmed that the product "meets high safety, health and environmental requirements."

Our dream is to give people around the world the opportunity to recover. To do this, we create exorehabilitation techniques, various versions of exoskeletons with which we enter the markets. And each time we have to re-confirm their effectiveness and safety due to regulatory requirements. These are always different quests that require separate resources and not always pre-predicted time. The FDA is our next giant victory, said Ekaterina Bereziy, co-founder of ExoAtlet.

In addition to the preparatory stage, laboratory tests and clinical studies, ExoAtlet introduced a cGMP quality system (Current Good Manufacturing Process) in production. In preparation for the FDA inspection of the compliance of the enterprise system with the requirements of the cGMP, the company trained specialists, finalized the quality management system, while obtaining international certification according to ISO 13485:2016. In accordance with the requirements of the FDA, special attention was paid to the software component of the product ExoAtlet II, its resistance to cyber threats. Auditing of production located in South Korea for compliance with cGMP requirements will now be carried out systematically.

"ExoAtlet" is one of the companies that change the international community's understanding of Russian manufacturers of medical equipment. With the FDA certificate obtained, our resident has powerful evidence of the safety and quality of the most complex medical product ExoAtlet II. Thanks to the built-in functional electrical stimulation and biological feedback through the ability to determine patient effort, the US regulator-certified version of the exoskeleton allows for more effective rehabilitation training for patients with partially preserved lower limb functions. We are proud of the success of "ExoAtlet" and wish him success in entering a huge market, noted Natalia Polushkina, vice president, executive director of the Cluster of Biological and Medical Technologies of the Skolkovo Foundation.

In the future, the company plans to bring the exoskeleton for the rehabilitation of children and adolescents ExoAtlet Bambini to the international market. In 2021, the device received a registration certificate in Russia and already helps children with cerebral palsy learn to walk exactly and beautifully, and in the future become independent and independent members of society.^[2]

Exoskeleton is necessary for working with diagnoses such as spinal cord injury, stroke, multiple sclerosis, cerebral palsy, diseases associated with impaired cerebral circulation, diseases of the musculoskeletal system.

According to the SPARK-Interfax system, Exoatlet LLC was registered in 2014, a share of 72.62% is owned by Luxembourg-based ExoAtlet Global S.A. through Exo LLC, 24.63% are owned by Biofond RVC, 2.75% are owned by Back Office Consalt LLC Evgenia Selezneva.

Start of exoskeleton sales ExoAtlet Bambini in the Russian Federation

In February 2021, ExoAtlet announced the receipt in Russia of a registration certificate for the exoskeleton ExoAtlet Bambini, which is intended for the rehabilitation of children with cerebral palsy, multiple sclerosis and spinal cord injuries. More details here.

Entry of ExoAtlet II into the Russian market

As it became known on February 25, 2021, ExoAtlet successfully completed the tests and received a registration certificate for exoskeleton ExoAtlet II. The simulator became the second exoskeleton in the manufacturer's line to undergo medical certification on the Russian market.

ExoAtlet II is a robotic exercise machine for restoring walking skills in adults and adolescents. The number of anthropometric settings of the second-generation exoskeleton increased from 8 to 13. New fixing corset of simulator has increased wear resistance and possibility of combination with systems of patient's body weight unloading.

The developers improved the adjustment mechanism, which reduced the time for reconfiguring the exoskeleton by 20%. The new exoskeleton provides eight options for the path and pitch time, three walking speeds, it allows you to walk on uneven surfaces, including stairs. The patient's level of support adapts to his efforts.

Exoskeleton ExoAtlet II for recovery from stroke enters the Russian market

According to the developers, myechanotherapy has a proven effectiveness in treating stroke and other diseases. The technical solution of exoskeleton ExoAtlet II allows you to expand the list of indications for exorehabilitation.

One of the key features of ExoAtlet II, which the manufacturer draws attention to, is an integrated synchronized electrical stimulation system that allows the use of functional and neuroelectrostystimulation while walking in the exoskeleton. This increases the effectiveness of the rehabilitation process and significantly reduces the recovery time of the patient. The telemetry system implemented in the ExoAtlet allows you to digitize, analyze and in the future build a forecast of the effectiveness of training.

In accordance with the order of the Ministry of Health of the Russian Federation, from January 1, 2021, exoskeletons are included in the list of equipment of gyms for medical rehabilitation.^[3]

2020

Russian exoskeletons for medical rehabilitation enter the EU market

On August 21, 2020, Exoatlet announced the launch of its exoskeletons into the European market. The ExoAtlet model received the CE Mark and can now be used in the medical practice of EU countries.

According to the developers, the CE Mark certificate indicates that the products meet high requirements for safety, health and environmental protection.

We are in the same line with large companies - manufacturers of medical equipment. CE Mark opens for us the borders of not only the European Union. There are many non-European countries that accept CE Mark as the main certificate, in particular, the states of the Middle East, "said Ekaterina Bereziy, co-founder of Exoatlet.

Russian exoskeletons for medical rehabilitation enter the European market

According to her, local certification will be required, but it is already passing in a simplified mode. Globally, CE Mark is a certificate that gives doctors the right to use exoskeletons in their routine medical practice, she stressed.

Exoatlet notes that exoskeletons ExoAtlet created for the medical and social rehabilitation of patients with stroke, spinal cord injuries, cerebral palsy, multiple sclerosis and other nosologies.

By August 21, 2020, exoskeletons are ExoAtlet used in more than 50 medical centers in Russia, as well as in Asian countries. In the future, the company plans to receive a quality certificate from the Food and Drug Administration (FDA) in the United States.

The director of operational work of the cluster of biomedical technologies of the Skolkovo Foundation (Exoatlet is a resident of this cluster) Vladimir Egorov, exoskeletons have found their practical use in rehabilitation earlier than in industry or the military sphere, this is happening all over the world. Now Exoatlet will be able to cover a large share of this growing market, he stressed.^[4]

Obtaining European CE Mark

The company EkzoAtlet"," a resident, Skolkovo Foundation Biomedical Technology Cluster on August 21, 2020 announced that it had received the European a CE Mark quality sign for exoskeletons medical the social rehabilitation of ExoAtlet. Now the company's products can be used in the medical practice of countries. of the European Union

Exoskeletons ExoAtlet are intended for the medical and social rehabilitation of patients with stroke, spinal cord injuries, cerebral palsy, multiple sclerosis and other nosologies.

The CE quality mark confirms that the products meet high safety, health and environmental requirements. Thus, exoskeletons can ExoAtlet enter the entire European market, noted in ExoAtlet.

"We are in the same line with large companies - manufacturers of medical equipment. CE Mark opens for us the borders of not only the European Union. There are many non-European countries that accept CE Mark as the main certificate, in particular, the states of the Middle East. In addition to it, local certification is then required, but it is already in simplified mode. Globally, it is a certificate that gives doctors the right to use exoskeletons in their routine medical practice, "said Ekaterina Bereziy, co-founder of ExoAtlet.

Exoskeletons are ExoAtlet used in more than 50 medical centers in Russia, as well as in Asian countries. In the future, the company plans to receive a FDA quality certificate in the United States.

"ExoAtlet" is dynamically developing and has gone a long way to Skolkovo from a resident of the Center for Robotics of the Information Technology Cluster to a member of the BMT Cluster. Exoskeletons have found their practical use in rehabilitation earlier than in industry or the military, this happens around the world. Now ExoAtlet will be able to cover a large share of this growing market, "commented Vladimir Egorov, Director of Operations of the Biomedical Technology Cluster of the Skolkovo Foundation.

2018: Demonstration of an updated version of the rehabilitation exoskeleton

On April 24, 2018, the Skolkovo Technopark first demonstrated an updated version of the ExoAtlet rehabilitation medical exoskeleton, the development of the Skolkovo resident.

Demonstration of the updated exoskeleton ExoAtlet in the Skolkovo Technopark

In the presented version, myostimulation was added - a method of restorative treatment that affects the spinal cord to activate locomotor neurons and stimulate muscles during walking. At the same time, it became possible to adjust the width of the pelvis, putting legs, shin, told the Skolkovo ​ ​ Foundation.

The updated version of the exoskeleton ExoAtlet equipped with mechanisms for adjusting the width of the pelvis, putting legs, shin

In turn, an expanded control system allows you to limit the power of exoskeleton drives so that the patient can use his own muscles when walking.

The updated ExoAtlet makes it possible to use your own muscles when walking

According to the Skolkovo Foundation, ExoAtlet plans to supply its development to European markets.

This year we plan to begin certification of rehabilitation medical exoskeletons according to European standards. For us, European certification is an opportunity to discover a large number of different markets at once, including Latin America, "said Ekaterina Bereziy, CEO of ExoAtlet.

2016

ExoAtlet will help patients diagnosed with multiple sclerosis

In the fall of 2016, the first clinical studies in Russia began on the use of the ExoAtlet medical exoskeleton in the rehabilitation of patients diagnosed with multiple sclerosis.

The research takes place on the basis of the GBUZ MO "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky" under the leadership of the head of the department Sergey Kotov. The studies, which will last 2 months, will involve 20 pre-selected patients.

Bereziy Ekaterina, founder and CEO of ExoAtlet: "In Russia, more than 150 thousand people are diagnosed with multiple sclerosis and this disease is rapidly growing younger. We hope that these clinical studies will identify a new approach to rehabilitation and preservation of motor functions in patients with such a diagnosis. "

ExoAtlet - registered medical product

Medical exoskeleton ExoAtlet I is designed to help people with disabilities and can be used for both medical and social rehabilitation of people with musculoskeletal disorders. Since June 28, 2016, ExoAtlet products have been a medical product registered in Roszdrav (registration number RZN 2016/4360).

ExoAtlet is an exoskeleton for verticalization and walking of a patient with locomotor disorders of the lower limbs. Patients get the opportunity to walk, climb and go down stairs, sit down and get up without assistance. Patients normalize blood pressure, improve lung ventilation. Price: 3 million rubles

Clinical trials in the Arkhangelsk region

In 2016, the Arkhangelsk Region Development Corporation launched clinical tests of the exoskeleton with the participation of pilot patients from Arkhangelsk and the regions of the region, and one of the first pilots was Sergey Rubinstein, who performed the sacrament of wedding in the exoskeleton for the first time in the history of Russia.

2011: Ministry of Emergencies and Moscow State University began work on the ExoAtlet project

In 2011, the EMERCOM of Russia and the scientific team of Moscow State University began work on the ExoAtlet project. Two years later, the first operating prototype of the exoskeleton in Russia was introduced.

Robotics

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